A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
19 mars 2015 mis à jour par: AstraZeneca
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone.
The safety and tolerability of the three treatment regimens will also be compared.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
514
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Bangalore, Inde
- Research Site
-
Indore, Inde
- Research Site
-
Karnal, Inde
- Research Site
-
Mumbai, Inde
- Research Site
-
Pune, Inde
- Research Site
-
-
-
-
-
Toluca, Mexique
- Research Site
-
-
Distrito Federal
-
Mexico City, Distrito Federal, Mexique
- Research Site
-
-
Jalisco
-
Guadalajara, Jalisco, Mexique
- Research Site
-
Zapopan, Jalisco, Mexique
- Research Site
-
-
Morelos
-
Cuernavaca, Morelos, Mexique
- Research Site
-
-
NuevoLeon
-
Monterrey, NuevoLeon, Mexique
- Research Site
-
-
-
-
Arizona
-
Peoria, Arizona, États-Unis
- Research Site
-
-
California
-
Artesia, California, États-Unis
- Research Site
-
Concord, California, États-Unis
- Research Site
-
Encino, California, États-Unis
- Research Site
-
Greenbrae, California, États-Unis
- Research Site
-
La Mesa, California, États-Unis
- Research Site
-
Orange, California, États-Unis
- Research Site
-
Walnut Creek, California, États-Unis
- Research Site
-
Whittier, California, États-Unis
- Research Site
-
-
Colorado
-
Colorado Springs, Colorado, États-Unis
- Research Site
-
-
District of Columbia
-
Washington, District of Columbia, États-Unis
- Research Site
-
-
Florida
-
Coral Gables, Florida, États-Unis
- Research Site
-
Deland, Florida, États-Unis
- Research Site
-
Melbourne, Florida, États-Unis
- Research Site
-
Miami, Florida, États-Unis
- Research Site
-
New Port Richey, Florida, États-Unis
- Research Site
-
-
Georgia
-
Decatur, Georgia, États-Unis
- Research Site
-
-
Indiana
-
Avon, Indiana, États-Unis
- Research Site
-
-
Kansas
-
Wichita, Kansas, États-Unis
- Research Site
-
-
Kentucky
-
Paducah, Kentucky, États-Unis
- Research Site
-
-
Louisiana
-
Baton Rouge, Louisiana, États-Unis
- Research Site
-
New Orleans, Louisiana, États-Unis
- Research Site
-
-
Maryland
-
Oxon Hill, Maryland, États-Unis
- Research Site
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis
- Research Site
-
-
Michigan
-
Chelsea, Michigan, États-Unis
- Research Site
-
Ypsilanti, Michigan, États-Unis
- Research Site
-
-
Minnesota
-
St. Louis Park, Minnesota, États-Unis
- Research Site
-
-
Missouri
-
St. Louis, Missouri, États-Unis
- Research Site
-
-
Montana
-
Butte, Montana, États-Unis
- Research Site
-
-
Nebraska
-
Lincoln, Nebraska, États-Unis
- Research Site
-
-
Nevada
-
Las Vegas, Nevada, États-Unis
- Research Site
-
-
New York
-
New Hyde Park, New York, États-Unis
- Research Site
-
New Windsor, New York, États-Unis
- Research Site
-
New York, New York, États-Unis
- Research Site
-
Rochester, New York, États-Unis
- Research Site
-
-
North Carolina
-
Durham, North Carolina, États-Unis
- Research Site
-
Statesville, North Carolina, États-Unis
- Research Site
-
Winston-Salem, North Carolina, États-Unis
- Research Site
-
-
Ohio
-
Athens, Ohio, États-Unis
- Research Site
-
Cincinnati, Ohio, États-Unis
- Research Site
-
Dayton, Ohio, États-Unis
- Research Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis
- Research Site
-
-
South Dakota
-
Rapid City, South Dakota, États-Unis
- Research Site
-
-
Tennessee
-
Memphis, Tennessee, États-Unis
- Research Site
-
-
Texas
-
Austin, Texas, États-Unis
- Research Site
-
Dallas, Texas, États-Unis
- Research Site
-
San Antonio, Texas, États-Unis
- Research Site
-
-
Virginia
-
Richmond, Virginia, États-Unis
- Research Site
-
-
Washington
-
Olympia, Washington, États-Unis
- Research Site
-
Spokane, Washington, États-Unis
- Research Site
-
Tacoma, Washington, États-Unis
- Research Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Has been diagnosed with type 2 diabetes mellitus
- Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
- Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
- Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents
Exclusion Criteria:
- Has been previously exposed to exenatide once weekly
- Has donated blood within 60 days of study start or is planning to donate blood during the study
Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
- Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
- Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
- Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
- Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
- Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
- Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 1
|
injection sous-cutanée, 2,0 mg, une fois par semaine
oral tablet, once a day
|
|
Comparateur actif: 2
|
oral tablet, 100mg, once a day
Autres noms:
subcutaneous injection, once a week
|
|
Comparateur actif: 3
|
subcutaneous injection, once a week
oral tablet, 45mg, once a day
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in HbA1c From Baseline to Week 26
Délai: Day 1, Week 26
|
Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].
|
Day 1, Week 26
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Délai: Week 26
|
Percentages of subjects achieving HbA1c target values of <7% at Week 26.
|
Week 26
|
|
Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
Délai: Week 26
|
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.
|
Week 26
|
|
Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
Délai: Week 26
|
Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.
|
Week 26
|
|
Change in Body Weight From Baseline to Week 26
Délai: Day 1, Week 26
|
Change in body weight from baseline (Day 1) to Week 26.
|
Day 1, Week 26
|
|
Change in Fasting Plasma Glucose From Baseline to Week 26
Délai: Day 1, Week 26
|
Change in fasting plasma glucose from baseline (Day 1) to Week 26.
|
Day 1, Week 26
|
|
Change in Systolic Blood Pressure From Baseline to Week 26
Délai: Day 1, Week 26
|
Change in systolic blood pressure from baseline (Day 1) to Week 26.
|
Day 1, Week 26
|
|
Change in Diastolic Blood Pressure From Baseline to Week 26
Délai: Day 1, Week 26
|
Change in diastolic blood pressure from baseline (Day 1) to Week 26.
|
Day 1, Week 26
|
|
Change in Fasting Total Cholesterol From Baseline to Week 26
Délai: Day 1, Week 26
|
Change in fasting total cholesterol from baseline (Day 1) to Week 26.
|
Day 1, Week 26
|
|
Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
Délai: Day 1, Week 26
|
Change in fasting HDL from baseline (Day 1) to Week 26.
|
Day 1, Week 26
|
|
Ratio of Fasting Triglycerides at Week 26 to Baseline
Délai: Day 1, Week 26
|
Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1).
Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
|
Day 1, Week 26
|
|
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
Délai: Day 1 to Week 26
|
Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment.
Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.
|
Day 1 to Week 26
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
- Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
- Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013.
- Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
- Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125.
- Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.
- Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14. doi: 10.1111/j.1464-5491.2011.03301.x.
- Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. doi: 10.1016/S0140-6736(10)60590-9. Epub 2010 Jun 26.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2008
Achèvement primaire (Réel)
1 février 2009
Achèvement de l'étude (Réel)
1 juillet 2009
Dates d'inscription aux études
Première soumission
6 mars 2008
Première soumission répondant aux critères de contrôle qualité
10 mars 2008
Première publication (Estimation)
17 mars 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 avril 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 mars 2015
Dernière vérification
1 mars 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Inhibiteurs de protéase
- Agents anti-obésité
- Incrétines
- Inhibiteurs de dipeptidyl-peptidase IV
- Pioglitazone
- Phosphate de sitagliptine
- Exénatide
Autres numéros d'identification d'étude
- BCB106 (DURATION - 2)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .